A Phase I Clinical Study of Recombinant Humanized Anti-BTLA Monoclonal Antibody (JS004) Injection Combined With Toripalimab Injection in Patients With Advanced Solid Tumors

NCT05427396 | Terminated Phase 1

• 1 other identifier: JS004-005-I
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

Brief Summary

This is an open-label phase I study to evaluate the safety, tolerability, and initial efficacy of JS004 injection combined with Toripalimab Injection in patients with advanced solid tumors who have failed standard therapy.

Conditions

Liver Cancer, Esophageal Squamous Cell Carcinoma, Gastric Adenocarcinoma, Cervical Cancer, MSI-H Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• The incidence of adverse events (AE) and serious adverse events (SAE) were assessed

  Incidence and severity of adverse events (AE) and serious adverse events (SAE) as assessed according to NCI-CTCAE 5.0, as well as abnormalities in vital signs, electrocardiogram, and laboratory tests

  2 years

Secondary Outcomes (7)

• OS

  2 years

• DOR

  2 years

• DCR

  2 years

• PFS

  2 years

• ORR

  2 years

Other Outcomes (4)

• ORR

  2 years

• DOR

  2 years

• DCR

  2 years

Study Arms (1)

JS004 200 mg in combination with Toripalimab Injection 240 mg was administered every 3 weeks

OTHER

Drug: JS004; Drug: Toripalimab Injection

Interventions

JS004 DRUG

Usage and dosage: Inject 200mg once every 3 weeks

JS004 200 mg in combination with Toripalimab Injection 240 mg was administered every 3 weeks

Toripalimab Injection DRUG

Usage and dosage: Inject 240mg once every 3 weeks

JS004 200 mg in combination with Toripalimab Injection 240 mg was administered every 3 weeks

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign the informed consent form voluntarily;
• Patient (both sex) ≥ 18 and ≤70 years at the time of signing informed consent;
• Expected survival ≥ 3 months;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• Patients with advanced solid tumors confirmed histologically or cytologically
• At least one measurable lesion as a target lesion (RECIST v1.1 criteria);
• Agree to provide tumor tissue samples (provide fresh biopsy samples before treatment as far as possible;
• The patient has good organ function as indicated by screening laboratory results
• Males of reproductive potential or females of childbearing potential must use effective contraceptive methods (such as oral contraceptives, intrauterine device or barrier method combined with spermicide) during the trial and continue contraception for 6 months after the end of treatment;
• Good compliance and cooperated with the follow-up.

You may not qualify if:

• Any malignancy other than the disease under study within the past 5 years, except for malignancies that can be expected to be cured after treatment (including but not limited to adequately treated thyroid cancer, carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated surgically with curative intent);
• patients received systemic antitumor therapy (including chemotherapy, small-molecule targeted drug therapy, endocrine therapy, etc.) or local antitumor therapy within 4 weeks prior to 1st administration
• Received immunotherapy (including antibody and cell therapy) within 4 weeks prior to 1st administration
• Received allogeneic hematopoietic stem cell transplantation or solid organ transplantation in the past;
• Central nervous system metastases and/or cancerous meningitis
• Have or are suspected of having active autoimmune diseases, including but not limited to systemic lupus erythematosus rheumatoid arthritis inflammatory bowel disease autoimmune hepatitis
• A large amount of hydrothorax or ascites or pericardial effusion with clinical symptoms or requiring symptomatic treatment;
• Have serious cardiovascular and cerebrovascular diseases, such as poorly controlled hypertension (systolic blood pressure\>140mmHg and/or diastolic pressure\> 90mmHg) or pulmonary arterial hypertension; Unstable angina or had a myocardial infarction in the 6 months prior to study use and had coronary artery bypass grafting or stenting; Chronic heart failure with grade 2 heart function (NYHA); Degree above heart block; Left ventricular ejection fraction (LVEF)\<50%; Cerebrovascular accident (CVA) or transient ischemic attack (TIA) occurred within 6 months prior to medication
• Pulmonary disease: interstitial pneumonia, obstructive pulmonary disease and symptomatic bronchospasm;
• A positive result for human immunodeficiency virus (HIV) antibody test;
• Known active tuberculosis (TB).
• Live vaccine was administered within 4 weeks prior to 1st administration
• Major surgical procedures (as defined by the investigator, e.g., open biopsy, severe trauma, etc.) within 4 weeks prior to 1st administration
• Have a history of psychotropic drug abuse and unable to withdraw or have mental disorders;
• Pregnant or lactating woman;

Sponsors & Collaborators

• Shanghai Junshi Bioscience Co., Ltd.: lead
• Sponsor GmbH: collaborator

Study Sites (2)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Location

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Location

MeSH Terms

Conditions

Liver Neoplasms; Esophageal Squamous Cell Carcinoma; Uterine Cervical Neoplasms

Interventions

toripalimab

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Head and Neck Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single Group

Study Record Dates

• First Submitted: June 5, 2022
• First Posted: June 22, 2022
• Study Start: July 28, 2022
• Primary Completion: January 15, 2024
• Study Completion: January 15, 2024
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)